Human breast gross cystic disease has been investigated by C. D. Haagansen, Diseases of the Breast, Second Edition, Chapter 7, Cystic Disease of the Breast (W. B. Saunders, Philadelphia, 1971). It has been found that patients who develop this disease have approximately a four-fold increased indicence of breast carcinoma above normal. This data suggests a significant link between breast carcinoma and gross cystic disease.
Up to the present, biochemical analysis of breast cystic disease fluid had been limited and incomplete. High levels of CEA have been found in the fluid as well as high potassium levels indicating an intracellular-like ionic consistency. See, in this regard, two papers by J. Fleisher and coworkers:
Clin. Chem., 20/1, 41 (1974); and PA1 Memorial Sloan-Kettering Cancer Center Clinical Bulletin, pages 94-97 (1974).
A report of clinical evaluation of the GCDFP-15 immunoassay of the present invention has been published in Ann. Surg., 185, 279 (1977). Methods for diagnosing, identifying and detecting carcinoembryonic antigen are disclosed in U.S. Pat. No. 3,663,684. An assay for the A and B components of carcinoembryonic antigen is disclosed in U.S. Pat. No. 3,697,638.